FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE): A Phase II Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Median Duration of Response
研究概览
简要总结
This clinical trial will determine whether the addition of radiotherapy to standard of care systemic therapy improves objective progression-free survival compared to systemic therapy alone in patients with oligometastatic castration-resistant prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must have biopsy-confirmed adenocarcinoma of the prostate
- •Subjects must discontinue any prior systemic therapies (excluding GnRH agonist/antagonists) without PSA withdrawal effects if using first generation anti-androgens. Luteinizing hormone-releasing hormone (LHRH) analogues must be continued if they have not undergone orchiectomy. (Subjects who recently started systemic therapy for metastatic castration-resistant prostate cancer (mCRPC) are eligible to enroll if new therapy was started ≤ 14 days to consent date.)
- •Subjects must have progressive metastatic castration-resistant prostate cancer based on at least one of the following criteria while having castrate levels (<50 ng/dL) of testosterone:
- •A) PSA progression defined as a 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval.
- •B) Progression of bidimensionally measurable soft tissue or nodal metastasis by CT scan or MRI based on RECIST criteria
- •C) Progression of bone disease on bone scan as defined by two new lesions arising
- •Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5 treatment sites that can be treated within a radiotherapy treatment field.
- •Subjects must be medically fit to undergo radiotherapy and systemic therapy as determined by the treating physician.
- •ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
- •No prior invasive malignancy in the past 3-years. Exceptions include non-melanomatous skin cancer and in situ cancers of the bladder or head and neck are permissible.
- •Subjects must freely sign informed consent to enroll in the study.
- •Subjects must use contraception up to 90 days after last drug dose.
排除标准
- •Planned systemic therapy with Radium-223 dichloride or sipuleucel-T
- •Tumor requiring emergent radiation in view of provider
- •Life expectancy estimate of <3 months
- •Presence of known parenchymal brain metastasis
- •Uncontrolled intercurrent illness
- •Inability to undergo radiotherapy, systemic treatment, CTs or bone scans
- •Biopsy proven pure small cell or neuroendocrine prostate cancer
研究组 & 干预措施
Standard of Care
Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol.
干预措施: Hormone therapy or chemotherapy (Drug)
Standard of Care + Ablative Radiation
Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol.
干预措施: Ablative Radiation Therapy (Radiation)
Standard of Care + Ablative Radiation
Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol.
干预措施: Hormone therapy or chemotherapy (Drug)
结局指标
主要结局
Median Duration of Response
时间窗: At 12 Months
Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. A patient's designated response at any one time is a combination of the assessment of target lesions, non-target lesions, bone lesions and disease symptoms. Progression in this measure is defined as worsened pain or new sites of disease on imaging. Progression by pain due to prostate cancer requires evidence of disease at the site of pain and one or more palliative intervention (opioid therapy for 10 out of 14 consecutive days, radionuclide therapy or radiation therapy). Response and progression definitions used will be a combination of the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1 and the Prostate Cancer Working Group 3.
次要结局
- Median Objective Progression Free Survival (PFS) Time(At 24 months)
- Median Prostate Specific Antigen (PSA) PFS(At 24 months)
- Median Radiographic PFS(At 24 months)
- Overall Survival Time(24 months)
- Prostate Cancer Specific Survival Time(24 months)
- Non-irradiated Metastases Free Survival Time(At 24 months)
- The Proportion of Patients With Complete PSA Response(24 months)
- The Proportion of Patients With a PSA Partial Response 50 (PR50)(24 months)
- The Proportion of Patients With a PSA Partial Response 90 (PR90)(24 months)
- The Proportion of Patients That Respond to Treatment(24 months)
- Patient-reported Outcome Based on NCCN-FACT FPSI-17 (Version 2)(measured at 6 and 12 months post starting treatment)